Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409682
Status:
COMPLETED
Last Update Posted:
2011-08-04
First Post:
2006-12-08
Brief Title:
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohns Disease
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Multi-Center Double-Blind Study to Evaluate the Safety Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohns Disease
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine Efficacy Pharmacokinetics and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohns Disease
Detailed Description:
M06-806 NCT NCT00409682 was a Phase 3 multi-center randomized double-blind DB efficacy safety and pharmacokinetic PK study designed to evaluate the efficacy of 2 dose regimens for the induction and maintenance of clinical remission in pediatric subjects between the ages of 6 and 17 inclusive with moderate to severe Crohns disease CD defined by Pediatric Crohns Disease Activity Index PCDAI 30 Subjects must have either failed conventional therapy for CD or have previously received infliximab and lost responsehad intolerance to infliximab
Approximately 186 pediatric subjects between the ages of 6 and 17 were planned to be entered into the study at approximately 55 sites in the US Canada and Europe At least 80 subjects were to be 13 years old at Baseline and one-third to one-half of the study population were to be subjects who had previously lost response or were intolerant to infliximab
The duration of the study was to be up to 65 weeks which included a 1- to 3-week Screening period an Induction period a Maintenance period and a 70-day follow-up phone call for all subjects that either terminated early from the study or did not rollover into the extension study NCT 00686374 to evaluate the long-term maintenance of clinical response safety and tolerability of repeated administration of adalimumab
All subjects received an induction regimen administered at Baseline Week 0 and Week 2 The open-label OL induction dose was based on the subjects Baseline body weight Subjects weighing 40 kg were to receive 160 mg at Week 0 and 80 mg adalimumab at Week 2 Subjects weighing 40 kg were to receive 80 mg at Week 0 and 40 mg adalimumab at Week 2
At Week 4 subjects were to be randomized 11 to 1 of 2 DB maintenance treatment groups Low-Dose or High-Dose stratified by Week 4 clinical responder status clinical response was defined as decrease in PCDAI of 15 points from the Baseline score body weight at Week 4 and prior exposure to infliximab Subjects randomized to the High-Dose treatment group were to receive either 40 mg adalimumab subcutaneous SC every other week eow if Week 4 body weight 40 kg or 20 mg adalimumab SC eow if Week 4 body weight 40 kg Subjects randomized to the Low-Dose treatment group were to receive either 20 mg adalimumab SC eow if Week 4 body weight 40 kg or 10 mg adalimumab SC eow if Week 4 body weight 40 kg
Subjects body weight taken at Week 26 was to be used to readjust the maintenance dosing regimen for a subject whose body weight had increased from 40 kg to 40 kg during the study
Subjects were expected to remain on blinded eow therapy throughout the 48-week study DB Maintenance period However starting at the Week 12 study visit subjects who experienced a disease flare increase in the PCDAI 15 points when compared to Week 4 and an absolute PCDAI above 30 or were non-responders not achieving a decrease in the PCDAI score of at least 15 points when compared to the Baseline score for 2 consecutive visits at least 2 weeks apart could be switched from blinded eow dosing to blinded every week ew dosing continuing with the same blinded dose During blinded ew treatment if a subject continued to experience a flare or met the definition of non-response following an 8 week course of DB ew therapy they were to be switched to OL ew therapy The dosage of the OL ew therapy was 20 mg for subjects 40 kg and 40 mg for subjects 40 kg
This study used the PCDAI to determine efficacy of the study drug The primary efficacy endpoint is the proportion of subjects who are in clinical remission at Week 26 as measured by the PCDAI in the intent-to-treat population Clinical remission is defined as a PCDAI score of 10
The clinical response indicators include clinical remission as defined by PCDAI score at Week 52 and clinical response as defined by PCDAI score at Week 26 and at Week 52
The patient reported outcome is the change from Baseline in total IMPACT III scores at Week 26 and Week 52
The safety parameters adverse events laboratory data and vital signs were assessed at all visits throughout the study
Approximately 186 pediatric subjects between the ages of 6 and 17 were planned to be entered into the study at approximately 55 sites in the US Canada and Europe At least 80 subjects were to be 13 years old at Baseline and one-third to one-half of the study population were to be subjects who had previously lost response or were intolerant to infliximab
The duration of the study was to be up to 65 weeks which included a 1- to 3-week Screening period an Induction period a Maintenance period and a 70-day follow-up phone call for all subjects that either terminated early from the study or did not rollover into the extension study NCT 00686374 to evaluate the long-term maintenance of clinical response safety and tolerability of repeated administration of adalimumab
All subjects received an induction regimen administered at Baseline Week 0 and Week 2 The open-label OL induction dose was based on the subjects Baseline body weight Subjects weighing 40 kg were to receive 160 mg at Week 0 and 80 mg adalimumab at Week 2 Subjects weighing 40 kg were to receive 80 mg at Week 0 and 40 mg adalimumab at Week 2
At Week 4 subjects were to be randomized 11 to 1 of 2 DB maintenance treatment groups Low-Dose or High-Dose stratified by Week 4 clinical responder status clinical response was defined as decrease in PCDAI of 15 points from the Baseline score body weight at Week 4 and prior exposure to infliximab Subjects randomized to the High-Dose treatment group were to receive either 40 mg adalimumab subcutaneous SC every other week eow if Week 4 body weight 40 kg or 20 mg adalimumab SC eow if Week 4 body weight 40 kg Subjects randomized to the Low-Dose treatment group were to receive either 20 mg adalimumab SC eow if Week 4 body weight 40 kg or 10 mg adalimumab SC eow if Week 4 body weight 40 kg
Subjects body weight taken at Week 26 was to be used to readjust the maintenance dosing regimen for a subject whose body weight had increased from 40 kg to 40 kg during the study
Subjects were expected to remain on blinded eow therapy throughout the 48-week study DB Maintenance period However starting at the Week 12 study visit subjects who experienced a disease flare increase in the PCDAI 15 points when compared to Week 4 and an absolute PCDAI above 30 or were non-responders not achieving a decrease in the PCDAI score of at least 15 points when compared to the Baseline score for 2 consecutive visits at least 2 weeks apart could be switched from blinded eow dosing to blinded every week ew dosing continuing with the same blinded dose During blinded ew treatment if a subject continued to experience a flare or met the definition of non-response following an 8 week course of DB ew therapy they were to be switched to OL ew therapy The dosage of the OL ew therapy was 20 mg for subjects 40 kg and 40 mg for subjects 40 kg
This study used the PCDAI to determine efficacy of the study drug The primary efficacy endpoint is the proportion of subjects who are in clinical remission at Week 26 as measured by the PCDAI in the intent-to-treat population Clinical remission is defined as a PCDAI score of 10
The clinical response indicators include clinical remission as defined by PCDAI score at Week 52 and clinical response as defined by PCDAI score at Week 26 and at Week 52
The patient reported outcome is the change from Baseline in total IMPACT III scores at Week 26 and Week 52
The safety parameters adverse events laboratory data and vital signs were assessed at all visits throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-004814-41 | EUDRACT_NUMBER | None | None |